BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH

    MDR report key: 1052889 · Received May 15, 2008

    Report

    Report Number
    1052889
    Event Type
    Malfunction
    Date Received
    May 15, 2008
    Date of Event
    April 19, 2008
    Report Date
    April 25, 2008
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    INFANT HAD A 6FR FOLEY CATHETER IN PLACE. IT HAD BEEN PLACED 19 HOURS BEFORE AND WAS WELL SECURED TO THE INFANT'S THIGH. THE RN NOTICED THE CATHETER HAD BROKEN AT THE PROXIMAL JUNCTION WHERE THE FOLEY CONNECTS TO THE DRAINAGE SYSTEM. THIS LEFT THE FOLEY IN THE PATIENT WITH APPROX 8 INCHES OUTSIDE OF THE PATIENT UNSTERILE AND DRAINING ONTO THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH CATHETER, FOLEY KOD TELEFLEX MEDICAL PRODUCT # 170003060 07DE17

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO